Liability and Risk

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Liability and Risk
William D. Marler, Esq. bmarler_at_marlerclark.com
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Lettuce and Spinach

• 19 E. coli outbreaks since 1995
• 409 reported illnesses
• two deaths
• Fresh or fresh-cut lettuce or spinach implicated
  as outbreak vehicle
• 8 outbreaks traced back to produce from Salinas,
  California

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Recent Lettuce Outbreaks

• July 2002 WA Dance Camp
• 50 dance campers sickened, several hospitalized,
  one with life-long kidney damage
• Pre-washed lettuce
• September 2003 CA Restaurant
• 40 patrons ill
• Salads prepared with bagged, pre-washed lettuce
  

• October 2003 CA Retirement Center
• 13 residents sickened, 2 died
• Pre-washed spinach

Lettuce from all three outbreaks came from
Californias Salinas Valley.
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Prior FDA Warnings

• 1998 FDA Guide to Minimize Microbial Food
  Safety Hazards for Fruits and Vegetables.
• Specifically designed to assist growers and
  packers in the implementation of safer
  manufacturing practices.
• 2004 FDA letter to the lettuce and tomato
  industries
• To make them aware of FDAs concerns regarding
  continuing outbreaks associated with these two
  commodities and to encourage the industries to
  review their practices.

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Dole Lettuce E. coli Outbreak Fall 2005

• September 22-29, 2005
• MN DOH lab receives 10 human E. coli O157H7
  isolates for subtyping
• PFGE shows that all 10 share unique 2 restriction
  enzyme combination
• September 28, 2005
• Illness linked epidemiologically to consumption
  of Dole pre-packaged lettuce

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Dole Lettuce E. coli Outbreak Fall 2005

• October 3, 2005
• MN Dept. of Ag isolates E. coli O157H7 in Dole
  lettuce obtained from households of
  case-patients
• October 5, 2005
• Oregon resident with O157, PFGE match to
  outbreak strain. Reports eating lettuce prior
  to symptom onset.

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Dole Lettuce E. coli Outbreak Summary

• 23 laboratory-confirmed cases of E. coli O157H7
  7 epi linked cases
• September 16 to September 30 onset
• 2 cases of HUS
• Cases in MN, OR, and WI
• Statistically associated with eating Dole
  pre-packaged lettuce
• Smoking Gun
• found in bag

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FDA Adulterated 2005

• FDA cited to research linking some or all of the
  outbreaks to sewage exposure, animal waste, and
  other contaminated water sources. The research
  further indicated that industry practices,
  including irrigation and field drainage methods,
  may have led directly to the contamination of the
  lettuce with E. coli O157H7.
• FDA considers adulterated any ready to eat
  crops produced under unsanitary conditions
  402(a)(4) of the Food, Drug, and Cosmetic Act

In light of continuing outbreaks associated with
fresh and fresh-cut lettuce and other leafy
greens, particularly from California, we are
issuing this second letter to reiterate our
concerns and to strongly encourage firms in your
industry to review their current operations.
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CADOHS to Western Growers - 2006

• A reassessment of current manure composting
  regulationsin light of recent scientific
  findings.
• An assessment ofseptic tank systems that may
  leak/flow into agricultural ditches or creeks
  bordering fields used to grow ready-to-eat
  produce.
• An assessment offarm worker access to portable
  toilets and hand washing facilities.

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CADOHS to Western Growers 2006, cont.

• An assessment of the locations of fields known to
  flood frequently.
• An assessment of the need formandatory GAPs
  and/or HAACP Plans.

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Dole and Natural Selections Fall 2006

• 199 persons infected with outbreak strain of E.
  coli O157H7 from 26 states.
• 102 (51) hospitalized
• 31 (16) developed hemolytic-uremic syndrome
  (HUS)
• Three confirmed deaths
• Maryland investigating possible fourth

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Dole and Natural Selections Fall 2006

• E. coli O157H7
• Isolated from 13 packages of DOLE spinach
• DNA fingerprints of all 13 match the outbreak
  strain
• Supplied by patients living in 10 states
• Eleven packages with lot codes consistent with a
  single manufacturing facility on a particular day

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The Smoking Cow Pie
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Cross-Border Connection?

• E. coli sickens many in Ontario
• TORONTO (CP) - More than 30 people in two Ontario
  cities may have fallen ill from eating lettuce
  tainted with potentially deadly E. coli, but
  there's no longer any need for concern, health
  authorities said Friday.

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The Legal Standard Strict Liability

• The focus is on the product not the conduct
• They are liable if
• The product was unsafe
• The product caused the injury

STRICT LIABILITY IS LIABILITY WITHOUT REGARD TO
FAULT.
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Who is a Manufacturer?

• A manufacturer is defined as a product seller
  who designs, produces, makes, fabricates,
  constructs, or remanufactures the relevant
  product or component part of a product before its
  sale to a user or consumer.
• RCW 7.72.010(2) see also Washburn v. Beatt
  Equipment Co., 120 Wn.2d 246 (1992)

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Its called STRICT Liability for a Reason

• The only defense is prevention
• Wishful thinking does not help
• If they manufacture a product that causes someone
  to be sick they are going to pay IF they get
  caught

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Negligence The legal standard applied to
non-manufacturers
The reason for excluding non-manufacturing
retailers from strict liability is to distinguish
between those who have actual control over the
product and those who act as mere conduits in the
chain of distribution. See Butello v. S.A.
Woods-Yates Am. Mach. Co., 72 Wn. App. 397, 404
(1993).
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Punitive (or Exemplary) Damages

• Punish the defendant for its conduct
• Deter others from similar conduct.

Historically, such damages were awarded to
discourage intentional wrongdoing, wanton and
reckless misconduct, and outrageous behavior.
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Causation Science

• Causation is an essential concept in
  epidemiology, yet there is no single, clearly
  articulated definition . J Epidemiol
  Community Health 2001Dec55(12)905-12
  Parascandola M, Weed DL.
• Confidence Interval (CI) Range within which 95
  of times the true value of the estimated
  association lies (95 CI)

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Causation The Law

• A proximate cause of an injury is a cause which,
  in natural and continuous sequence, produces the
  injury, and without which the injury would not
  have likely occurred. The concept of proximate
  causation has given courts and commentators
  consummate difficulty and has in truth defied
  precise definition.
• Prosser, Torts, pp. 311-313
• However, It really is what is more likely than
  not. It is 50 and an extra grain of sand.
  Marler on the law

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But, Causation Still Requires Admissible Evidence

• Whether a theory or technique can be (and has
  been) tested
• Whether it has been published and subjected to
  peer review
• Whether it has a high potential rate of error
• Whether it enjoys general acceptance in the
• scientific community
• Daubert v. Merrell Dow Pharm., Inc., 509 U.S.
  579 (1993).

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Will Industry Continue to Learn from Outbreaks?

• Good Reasons
• Bad idea to poison customers
• moral reasons
• business reasons
• Puts Trial Lawyers out of business
• please!